The Effects of Gyngerlean Supplementation on Energy Expen... | NCT06805201

Studies
The Effects of Gyngerlean Supplementation on Energy Expenditure

NCT06805201

Sponsor

Nova Southeastern University

Status

Completed

Last Update Posted

Feb 3, 2025Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

No Disease or Condition is Being Studied
Metabolism

Interventions

Gyngerlean

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 23, 2024Actual

Primary Completion Date

Aug 8, 2024Actual

Completion Date

Aug 8, 2024Actual

First Submitted Date

Jan 21, 2025

First Submission Date that Met QC Criteria

Jan 29, 2025

First Posted Date

Feb 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2025

Last Update Posted Date

Feb 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this randomized controlled study is to asses the effects of a ginger containing supplement on energy expenditure and substrate utilization in healthy men. The main questions it aims to answer are"

The effects of Kaempferia parviflora extract on energy expenditure
The effects of Kaempferia parviflora extract on substrate utilization

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supplement 1	Experimental	GyngerLean™ 100 mg	Dietary Supplement: Gyngerlean
Supplement 2	Experimental	GyngerLean™ 200 mg	Dietary Supplement: Gyngerlean

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gyngerlean	Dietary Supplement	Alpinia galangal (Red Ginger), Kaempferia parviflora (Black Ginger), and Zingiber officinale (Yellow Ginger).	Supplement 1 Supplement 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting Metabolic rate	The amount of energy/calories the body needs to function while at rest.	180 minutes

Secondary Outcomes

Measure	Description	Time Frame
Respiratory quotient	The ratio between carbon dioxide production and oxygen consumption.	180 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Active adults. Active is defined as exercising 3 or more times a week for 30 minutes.

Exclusion Criteria:

Participants must not be diabetics, have Celiac disease, or individuals with pre-existing heart or kidney disease.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lia Jiannine	ljiannine@nova.edu	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nova Southeastern University		Davie	Florida	333328	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided